Are dietary supplements regulated as foods or drugs?

Are dietary supplements regulated as foods or drugs?

All prescription and non-prescription drugs are regulated in the United States by the Food and Drug Administration (FDA). But dietary supplements are treated more like special foods.

The answer is YES, although dietary 

supplements are regulated by the FDA as 

foods, they are regulated differently from 

other foods and from drugs. 

Most often, classification as a 

dietary supplement is determined by the 

information that the manufacturer

provides on the product label or in accompanying literature, although many food and dietary supplement product labels do not include this information.

Whether a product is classified as a 

dietary supplement, conventional food, or 

drug is based on its intended use.

How is a product’s intended use 

established?

Claims stated on the product 

labeling, in advertising, on the Internet, 

or in other promotional materials.

Certain claims may cause a product to be 

considered a drug, even if the product is 

marketed as if it were a cosmetic. 

Such claims establish the product as a 

drug because the intended use is to treat 

or prevent disease or otherwise affect the 

structure or functions of the human body. 

The label of a dietary supplement or 

food product may contain one of three 

types of claims: 

A Health Claim describes a relationship 

between a food, food component, or dietary supplement ingredient, and reducing risk 

of a disease or health-related condition. 

A Nutrient Content Claim describes 

the relative amount of a nutrient or dietary 

substance in a product.

Are Nutraceuticals regulated by the FDA?

Here are the chief regulation differences 

between Drugs & Medicines and Supple-

ments & Cosmetics

1• A drug is a single chemical substance 

in a medicine that alters the structure or 

function of some of the body’s biological 

processes. A medicine is drug (or 

combination of drugs) that is intended to 

prevent illness, cure diseases and relieve 

pain.

2• Companies seeking approval to sell a drug must test their product in a laboratory and with animal tests to discover how 

the drug works and whether it’s safe and 

can work well in humans. Next, a series 

of tests in humans is begun to determine 

whether the drug is safe when used to 

treat a disease and whether it provides a 

real health benefit.

3• Supplements are regulated by FDA with a kind of “recipe book” covering acceptable 

ingredients, doses, formulations, and 

labeling. Products conforming to this 

may be marketed without further FDA 

clearance.

4• Supplements and medicines undergo 

different monitoring requirements set 

forth by the FDA. Supplements, like 

the Omega-3 fatty acid supplementsare classified as a “food” by the FDA. 

This means that it is the manufacturer’s 

responsibility to make sure that 

the supplements are safe, free of 

contaminants, correctly labeled, and 

made in a safe and clean environment.

5• Prescription medicines, on the other 

hand, are monitored a little bit 

differently. For instance, prescription 

Omega-3 fatty acids, must undergo 

extensive testing before they can be sold 

in pharmacies. The manufacturers must 

prove to the FDA that the drug works 

how it is supposed to, that it is safe, any 

adverse effects of the drug, and that it 

contains all of the ingredients stated on 

the label.

What does drug mean?

• Prescribed by a doctor or medical practitioner

• Bought at a pharmacy shop

• Prescribed for and intended to be used 

by the specific person 

• Drug manufacturers may claim that 

their product will diagnose, cure, 

mitigate, treat, or prevent a disease

What does Supplements mean?

• Foods that do NOT require a doctor’s 

prescription 

• Easily available to the public

• Medical claims may not legally be made 

for dietary supplements.

conclusion:

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